MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2022

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that an rl incident took place at the facility and that logs on the complaint device needed to be pulled to make sure that alarms were triggered when they were supposed to be triggered.The event occurred in the ed room and involved an oxygen saturation alarms at 3:55 am, and an apnea alarm at 3:58 am.The customer sought confirmation if alarms were paused or silenced.

Event Description

It was reported that an rl incident took place at the facility and that logs on the complaint device needed to be pulled to make sure that alarms were triggered when they were supposed to be triggered.The event occurred in the ed room and involved an oxygen saturation alarms at 3:55am., and an apnea alarm at 3:58am.The customer sought confirmation if alarms were paused or silenced.It was later confirmed that an unspecified patient required a revival procedure.Additional information was provided by the customer which indicated that the "patient on full monitor in room 2 after receiving multiple doses of narcotic pain medication.Staff notified at 04:01 that patient was apneic and had sat of 22%.Patient bagged and given iv narcan with improvement in respiratory status and mental status.Upon review of the alarms, it appears patient started de-satting around 03:55." it was indicated by the customer that "there should have been at least 40 seconds of audible red alarms.At 3:58, no pulse ox was read, but there are apnea alarms.From there on, no pulse ox is read until 0401 when staff where in the room.From that research, it appears as though patient might have been apneic with no sats for 6 minutes with no staff aware of said issue." customer was unsure if anyone silenced any alarm.The customer speculated that "maybe that pause alarm on the monitor in the room that silences things for 3 minutes? staff was notified by fne who was in the room and noticed patient unresponsive." the patient underwent an unspecified revival procedure and no further issues were indicated.A philips remote service engineer (rse) was initially assigned to assist with the evaluation of the complaint device.Additionally, a philips technician was dispatched to the university of colorado to acquire event details and to extract the logs from the complaint device to aid in the investigation.Several good faith efforts were made by the philips complaint investigator to the attending philips technician to determine how the complaint device was evaluated and what resolution was offered to the customer following this event.Responses were provided by the philips technician which confirmed that on (b)(6) 2022, a twenty-one-year-old male patient presented to the university of colorado for an unspecified procedure.The patient was being fully monitored after receiving multiple doses of narcotic pain medication.The university of colorado staff were notified at 04:01 that patient was apneic and had an oxygen saturation of 22%.The patient was bagged and given iv narcan with improvement in respiratory and mental status.Upon review of the alarms, it appeared that the patient started desaturating around 03:55am.The staff of the university of colorado indicated that there should have been at least 40 seconds of audible red alarms during this time.At 03:58am, no pulse oxygen was read, but there were apnea alarms.The staff of the university of colorado then indicated that no pulse oxygen was read until 04:01am, when facility staff entered the room.Despite several attempts to procure additional information on the patient's condition following this incident, no response was provided to aid in the investigation.The attending philips remote service engineer (rse) performed a remote evaluation of the complaint device.During this evaluation, the philips rse confirmed that no device malfunction had occurred, and that the device was operating according to specification.Additionally, philips conducted a review of the complaint device audit logs which were provided to the philips technician.It was confirmed that the complaint device alarm visual and audible latch settings were configured to the ¿off¿ setting.According to the instructions for use (ifu) for the mx700 device, the user is advised that the ¿alarm latching setting for your monitor defines how the alarm indicators behave when you do not acknowledge them.When alarms are set to non-latching, their indicators end when the alarm condition ends.Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends.The indication lasts until you acknowledge the alarm.¿ the instructions for use (ifu) then provides instructions on how to configure the complaint device to latch both visual and audio alarms.Furthermore, the ifu advises the user that when ¿using arrhythmia analysis, visual latching and audible latching should be on for red alarms, or at least visual latching should be on.Because of the transient nature of arrhythmia alarms, many arrhythmia conditions may go unnoticed if alarm latching is off.This setting can only be changed in configuration mode.¿.During the investigation, it was determined that the philips 865241, intellivue mx700 patient monitor alarm visual and audio latching settings had been turned off and were not configured to continuously alarm.When the alarm visual and audio latching is turned on, alarm indications will still be displayed or announced by the monitor after the alarm condition ends and will continue in this state until the alarm is acknowledged.Based on the review of the device configuration audit logs, and the philips remote service engineer evaluation of the complaint device, no device malfunction was found to have occurred.The philips 865241, intellivue mx700 patient monitor was functioning according to specification, therefore, no further investigation or action by philips is warranted at this time.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: INTELLIVUE MX700 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14601688
• MDR Text Key: 293347262
• Report Number: 9610816-2022-00315
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male